Tóm tắt công việc
Nghề | Nghề yêu cầu kỹ thuật (Bán hàng, Thiết kế, Phát triển, Quản lý sản xuất)/Quản lý sản xuất, Quản lý chất lượng, Quản lý thi công, EHS, PMS |
---|---|
Ngành | Y tế/ Các ngành y tế khác |
Hình thái tuyển dụng | Chưa phân loại |
Chức vụ | Khác |
Số lượng tuyển dụng | 1 người |
Ngày muốn vào làm | - |
Kỹ năng ngôn ngữ cần thiết |
Tiếng Nhật (Thành thạo) Tiếng Anh (Giao tiếp kinh doanh) |
Ngôn ngữ có thể sử dụng | - |
Thời gian làm việc | Khác |
Ngày nghỉ / Phúc lợi y tế | |
Hỗ trợ xin visa | - |
Nhân viên người nước ngoài | - |
Chi tiết công việc
Company Overview
【糖尿病領域シェアNo.1】定着率◎/ヨーロッパ系製薬メーカー
Job Description
Objectives:
- Establishment and maintenance of GQP/QMS system, and confirmation of GMP/QMS compliance in the factories manufacturing the products marketed in Japan
- Adequate handling of product quality information (including customer complaints), for risk management (to reduce potential recall situations) as well as for penetration of optimal use information/customer satisfaction
- Management of overseas factories’ affairs (accreditation maintenance and coordination for GMP/QMS inspection of PMDA and third parties)
- Quality assurance of product storage and distribution
Main Tasks:
1) Execution of activities for GQP/QMS-related requirements and quality of products assigned to team and group
2) Penetration of the optimal use in the market – in some cases, through the project organization
3) Execution of activities related to the regulations for overseas factories assigned to the team and group
4) Other duties such as the role in GQP organization
5) Other accountabilities: Responsibility of Specialist
- Support the group manager/department director, for establishment and achievement of Dept.’s BSC, especially about GQP/QMS compliance.
- For GQP/QMS compliance, couch/advise appropriately to the members of Dept. (disregarding the group)
- Coach daily the team member, and manage the teamwork.
- Keeping of good communication between department and global branches/HQ
Requirements
- Experience of Product Quality Assurance tasks
- Knowledge on company products (specifications, manufacturing process outline, etc.)
- Special Knowledge on GQP/GMP/QMS requirements
- Knowledge on company-specific quality system, especially audit & inspection, review system, etc.
Additional Job Information
Entitlements depend on experience level
Về cuộc phỏng vấn
Địa chỉ liên lạc
GQP&QMS Specialist
RGF HR Agent
600 〜 1000 ten thousand JPY